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FDA Accepts NDA for Preos, Treatment for Osteoporosis in Postmenopausal Women

SALT LAKE CITY, July 11 /PRNewswire-FirstCall/ -- NPS Pharmaceuticals, Inc. (NASDAQ:NPSP) announced today that as of July 9, 2005 the U.S. Food and Drug Administration (FDA) has accepted for review the company's new drug application (NDA) to market PREOS(R) (parathyroid hormone) for the treatment of osteoporosis in postmenopausal women. NPS submitted the application on May 10, 2005, and the FDA has now made a threshold determination that the PREOS(R) NDA is sufficiently complete to permit a substantive review.

Clinical results in the NDA are based upon data from 13 separate studies including an international multi-center Phase 3 trial of approximately 2,600 postmenopausal osteoporotic women who were randomized to receive either a daily subcutaneous injection of 100 micrograms of PREOS(R) or placebo, in addition to daily calcium and vitamin D supplements. The application also includes results from Phase 1 and Phase 2 studies with PREOS(R), open-label extension studies following the pivotal Phase 3 trial, and combination studies evaluating the use of PREOS(R) with other drugs, as well as preclinical data and data related to manufacturing the product.

A similar application to market PREOS(R) in Europe under the brand name PREOTACT(TM) is currently under review by the European Medicines Agency.

Source: NPS Pharmaceuticals

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